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Trial record 9 of 18 for:    cu-64

Somatostatin Receptor Imaging in Cardiac Sarcoidosis

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ClinicalTrials.gov Identifier: NCT02812849
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Rasmus S. Ripa, Rigshospitalet, Denmark

Tracking Information
First Submitted Date June 22, 2016
First Posted Date June 24, 2016
Last Update Posted Date September 27, 2017
Study Start Date June 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2016)
  • Sensitivity to detect cardiac sarcoidosis [ Time Frame: 1 day at PET/CT examination ]
  • Specificity to detect cardiac sarcoidosis [ Time Frame: 1 day at PET/CT examination ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02812849 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Somatostatin Receptor Imaging in Cardiac Sarcoidosis
Official Title Somatostatin Receptor Imaging in Cardiac Sarcoidosis
Brief Summary The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with suspected or known cardiac sarcoidosis or with myocarditis/dilated cardiomyopathy
Condition Cardiac Sarcoidosis
Intervention Drug: Cu-64 DOTATATE
Study Groups/Cohorts
  • Suspected cardiac sarcoidosis
    Cu-64 DOTATATE PET/CT or PET/MRI
    Intervention: Drug: Cu-64 DOTATATE
  • Known cardiac sarcoidosis
    Cu-64 DOTATATE PET/CT or PET/MRI
    Intervention: Drug: Cu-64 DOTATATE
  • Other inflammatory cardiac disease
    Cu-64 DOTATATE PET/CT or PET/MRI
    Intervention: Drug: Cu-64 DOTATATE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 23, 2016)
60
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Group A: Suspected cardiac sarcoidosis Group B: Known cardiac sarcoidosis, clinical follow-up Group C: Myocarditis or dilated cardiomyopathy (Non-cardiac sarcoidosis)

Exclusion Criteria:

Infection Pregnancy Severe claustrophobia Weight >140 kg

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rasmus S Ripa, MD, DMSc +4535453545
Contact: Finn Gustafsson, MD, DMSc
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02812849
Other Study ID Numbers 0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Rasmus S. Ripa, Rigshospitalet, Denmark
Study Sponsor Rigshospitalet, Denmark
Collaborators Not Provided
Investigators
Principal Investigator: Rasmus S Ripa, MD, DMSc Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date September 2017